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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Heart / Stent
Title   Registry Trial of stenting and angioplasty (Heart / Stent)
Description   Stenting and Angioplasty with Protection in Patients at High Risk for for the surgical removal of plaque from an artery that has become narrowed or blocked.
IRB Number   Pro253
Inclusion/Notes   INCLUSION:
  • This study is for subjects with narrowing of the carotid arteries also called carotid stenosis.

  • Patients that receive a Cordis PRECISE Nitinol Stent System and the Cordis ANGIOGUARD XP/RX Emboli Capture Guidewire (ECGW) are eligible to participate in this study.

  • Carotid stents are limited to patients with or without symptoms of carotid artery blockage.

  • Patients are deemed to be high risk for carotid endarterectomy (surgical removal of fatty material (plaque) in the carotid artery) are candidates for carotid stents.

  • These high risk patients can be deemed to be high risk for general anesthesia, wound healing, or difficult surgical access:
    a. These patients include those with recent heart attack or percutaneous coronary intervention (using a balloon catheter to open a coronary artery and the placement of a stainless steel mesh/stent).
    b. Severe coronary artery disease (build-up of fatty material in the arteries).
    c. Unstable angina (chest pain in/or around the heart), congestive heart failure (lung congestion).
    d. Renal insufficiency (poor kidney function), severe lung disease.
    e. An age greater than 80 years.

  • Also included, are patients who have developed restenosis (build-up of plaque after a surgical procedure) after carotid endarterectomy, inaccessible carotid anatomy (area cannot be accessed) and laryngeal nerve palsy (paralysis of nerve in the throat).

EXCLUSION:
  • Individuals who have contraindications (unable to use device and/or have procedure) for using either the Nitinol Stent System or the ANGIOGUARD Embolic capture device. These people include but are not limited to:
    a. Those in whom antiplatelet or anticoagulation (blood thinners) is contraindicated.
    b. People with uncorrected bleeding disorders.
    c. People with known allergies to Nitinol.
Status   Recruiting
Location   Texas Health Harris Methodist Hospital Hurst-Euless-Bedford
Principal Name    Srinivas N Paranandi MD
Contact Name   Sandra Hatley
Phone   (817) 848-4470

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